Easing the Burden of GMP Compliance

In a regulated laboratory, both instruments and methods must be validated to be suitable for their intended purposes. It is equally important, however, that personnel are properly trained and qualified for the task at hand. But in spite of this requirement, FDA still frequently cites firms for a lack of trained personnel. This month’s “Validation Viewpoint” examines how instrument vendors can ease the burden of training for GMP compliance.


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Author(s): 
Ira Krull , Michael E. Swartz .
Journal: 
LCGC North America, Sep 1, 2004 .